Rapid Diagnostic Testing for Response to the Monkeypox Outbreak — Laboratory Response Network, United States, May 17–June 30, 2022
Authors: Tricia A. Aden, Patricia Blevins, Shannon Whitman York, Stacy Rager, Devika Balachandran, Christina L. Hutson, David Lowe, Chris N. Mangal, Tyler Wolford, Audrey Matheny, Whitni Davidson, Kimberly Wilkins, Rachael Cook, Rebecca M. Roulo, Michael K. White, LaShondra Berman, Janna Murray, John Laurance, Drew Francis, Nicole M. Green, Ricardo A. Berumen, Anthony Gonzalez, Stacy Evans, Meghan Hudziec, Diane Noel, Michael Adjei, Gregory Hovan, Phil Lee, Lisa Tate, Remedios B. Gose, Robert Voermans, Jennifer Crew, Phillip R. Adam, Danielle Haydel, Salimatu Lukula, Nick Matluk, Sandip Shah, Joshua Featherston, Daphne Ware, Denise Pettit, Emily McCutchen, Edward Acheampong, Erin Buttery, Andrew Gorzalski, Michael Perry, Randal Fowler, Robert B. Lee, Robert Nickla, Richard Huard, Amanda Moore, Katie Jones, Renee Johnson, Erin Swaney, Juan Jaramillo, Cynthia Reinoso Webb, Brandon Guin, Janine Yost, Annette Atkinson, Latoya Griffin-Thomas, Jessica Chenette, Jessica Gant, Alana Sterkel, Harjinder K. Ghuman, James Lute, Sandra C. Smole, Vaneet Arora, Courtney K. Demontigny, Meilan Bielby, Evelyn Geeter, Kimberly A. M. Newman, Mark Glazier, Whitney Lutkemeier, Megan Nelson, Raymond Martinez, Jasmine Chaitram, Margaret A. Honein, Julie M. Villanueva
Journal: MMWR Morbidity and Mortality Weekly Report (2022)

As part of public health preparedness for infectious disease threats, CDC collaborates with other U.S. public health officials to ensure that the Laboratory Response Network (LRN) has diagnostic tools to detect Orthopoxviruses, the genus that includes Variola virus, the causative agent of smallpox. LRN is a network of state and local public health, federal, U.S. Department of Defense (DOD), veterinary, food, and environmental testing laboratories. CDC developed, and the Food and Drug Administration (FDA) granted 510(k) clearance* for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (non-variola Orthopoxvirus [NVO] assay), a polymerase chain reaction (PCR) diagnostic test to detect NVO. On May 17, 2022, CDC was contacted by the Massachusetts Department of Public Health (DPH) regarding a suspected case of monkeypox, a disease caused by the Orthopoxvirus Monkeypox virus. Specimens were collected and tested by the Massachusetts DPH public health laboratory with LRN testing capability using the NVO assay. Nationwide, 68 LRN laboratories had capacity to test approximately 8,000 NVO tests per week during June. During May 17-June 30, LRN laboratories tested 2,009 specimens from suspected monkeypox cases. Among those, 730 (36.3%) specimens from 395 patients were positive for NVO. NVO-positive specimens from 159 persons were confirmed by CDC to be monkeypox; final characterization is pending for 236. Prompt identification of persons with infection allowed rapid response to the outbreak, including isolation and treatment of patients, administration of vaccines, and other public health action. To further facilitate access to testing and increase convenience for providers and patients by using existing provider-laboratory relationships, CDC and LRN are supporting five large commercial laboratories with a national footprint (Aegis Science, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare) to establish NVO testing capacity of 10,000 specimens per week per laboratory. On July 6, 2022, the first commercial laboratory began accepting specimens for NVO testing based on clinician orders.